Neoadjuvant Erlotinib Therapy in Stage III A(N2) NSCLC - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 14, 2008

Last Updated Date

January 14, 2008

Start Date ^†

September 2007

Current Primary Outcome Measures ^†

Response to Neoadjuvant Erlotinib Therapy [ Time Frame: 14 days after Neoadjuvant Erlotinib Therapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

disease free survival [ Time Frame: by follow up ] [ Designated as safety issue: No ]
overall survival [ Time Frame: by follow up ] [ Designated as safety issue: No ]
complete resection rate [ Time Frame: 7 days after thoractomy ] [ Designated as safety issue: No ]
Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications [ Time Frame: one months after thoractomy ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Neoadjuvant Erlotinib Therapy in Stage III A(N2) NSCLC

Official Title ^†

Phase Ⅱ Study of Neoadjuvant Erlotinib Therapy in Stage III A(N2) Non-Small Cell Lung Cancer Proceeding to Mediastinoscopy and Surgery

Brief Summary

The purpose of this study is to evaluate the value of neoadjuvant Erlotinib therapy before thoracotomy in ⅢA-N2(confirmed by mediastinoscopy) non-small cell lung cancer(NSCLC) selected by epidermal growth factor receptor(EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^†

Carcinoma, Non-Small-Cell Lung

Intervention ^†

Drug: neoadjuvant erlotinib therapy
Drug: neoadjuvant gemcitabine/carboplatin therapy

Study Arms / Comparison Groups

Experimental: Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status:mutant-type OR high copy number OR (overexpression AND non-smokers))
Active Comparator: Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Resectable NSCLC of stage ⅢAN2 confirmed by mediastinoscopy.
Naive therapy NSCLC.
Candidates should be tolerated with neoadjuvant therapy and thoracotomy with ECOG performance status 0-2 and qualified lung function.

Exclusion Criteria:

SCLC.
Unresectable NSCLC of stage ⅢAN2.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Yi-long WU, MD	+86-020-83821484	gzyilong2006@hotmail.com
Contact: Xue-ning YANG, MD	+86-020-83821484	yangxuening@gmail.com

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600587

Responsible Party

Yi-long WU, Lung Cancer Research Institute, Guangdong Provincial People's Hospital

Secondary IDs ^††

ROCHE-123456-1

Study Sponsor ^†

Guangdong Provincial People's Hospital

Collaborators ^††

Hoffmann-La Roche

Investigators ^†

Principal Investigator:	Yi-long WU, MD	Guangdong Provincial People's Hospital
Study Chair:	Xue-ning YANG, MD	Guangdong Provincial People's Hospital
Study Director:	Wen-zhao ZHONG, MD	Guangdong Provincial People's Hospital

Information Provided By

Guangdong Provincial People's Hospital

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.